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U.S. FDA Medical Device Caloric-Water Stimulator Requirements


FDA Medical Device Definition: An air or water caloric stimulator is a device that delivers a stream of air or water to the ear canal at controlled rates of flow and temperature and that is intended for vestibular function testing of a patient's body balance system. The vestibular stimulation of the semicircular canals produce involuntary eye movements that are measured and recorded by a nystagmograph.

Registrar Corp assists Caloric-Water Stimulator companies with:

  • FDA Caloric-Water Stimulator Establishment Registration
  • FDA Caloric-Water Stimulator Listing
  • FDA Caloric-Water Stimulator Label Requirements and Exceptions
  • FDA Caloric-Water Stimulator Import Information
  • FDA Caloric-Water Stimulator Detentions (Caloric-Water Stimulator Entry Refusals)
  • General U.S. Food and Drug Administration Medical Device Guidelines for:
       - Caloric-Water Stimulator Manufacturers (Caloric-Water Stimulator Suppliers)
       - Caloric-Water Stimulator Distributors
       - Caloric-Water Stimulator Processors
       - Caloric-Water Stimulator Repackers
       - Caloric-Water Stimulator Relabelers
       - Caloric-Water Stimulator Exporters
       - Caloric-Water Stimulator Importers
For more information about Caloric-Water Stimulator Medical Devices, simply click below:






 
U.S. FDA Regulations:

U.S. FDA 510(k) Regulation: 21 C.F.R. section 814.9.


Registrar Corp assists businesses with U.S. FDA compliance. Certificates of Registration issued by Registrar Corp provide confirmation to industry that you are fulfilling U.S. FDA registration requirements. U.S. FDA does not issue or recognize Certificates of Registration. Registrar Corp is not affiliated with the U.S. Food and Drug Administration.
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